BMJ open · 2025
Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study).
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Hironaka Junya, Okada Hiroshi, Osaka Takafumi, Hashimoto Yoshitaka, Kobayashi Genki, Tanaka Muhei, Kogure Akinori, Mitsuhashi Kazuteru, Yoshimura Takashi, Kitagawa Noriyuki, Yano Miho, Kitamura Akane, Kishi Akio, Tsutsumi Takeshi, Yamazaki Masahiro, Ishii Michiyo, Mogami Shinichi, Nakamura Naoto, Fukuda Takuya, Tanaka Toru, Bamba Ryo, Sato Eiko, Hamaguchi Masahide, Fukui Michiaki
Аннотация
BACKGROUND: To effectively manage the progression of diabetic kidney disease, it is essential to address the associated hyperkalaemia while concurrently using renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists. In this study, we aim to evaluate the effects of administering sodium zirconium cyclosilicate (SZC) to patients with type 2 diabetes mellitus (T2DM) complicated by hyperkalaemia.
METHODS AND ANALYSIS: A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups.After consent, both groups will enter an initiation phase, receiving 10 g of SZC, three times per day for 2 days. SZC administration (5 g once daily) will subsequently commence in group A, while dietary therapy will be initiated in group B by implementing a potassium-restricted diet. The primary endpoint of the study is the proportion of normokalaemic (3.5 mEq/L≤serum potassium (sK)<5.0 mEq/L) participants at visit 7. The secondary endpoints are: (a) the proportion of normokalaemic participants (3.5 mEq/L≤sK<5.0 mEq/L) at visit 4 and (b) serum potassium levels at visit 7.
ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants prior to commencing the study. This study has been approved by the Kyoto Prefectural University of Medicine Clinical Research Review Board. All data obtained from this study will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: jRCTs051230067.
METHODS AND ANALYSIS: A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups.After consent, both groups will enter an initiation phase, receiving 10 g of SZC, three times per day for 2 days. SZC administration (5 g once daily) will subsequently commence in group A, while dietary therapy will be initiated in group B by implementing a potassium-restricted diet. The primary endpoint of the study is the proportion of normokalaemic (3.5 mEq/L≤serum potassium (sK)<5.0 mEq/L) participants at visit 7. The secondary endpoints are: (a) the proportion of normokalaemic participants (3.5 mEq/L≤sK<5.0 mEq/L) at visit 4 and (b) serum potassium levels at visit 7.
ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants prior to commencing the study. This study has been approved by the Kyoto Prefectural University of Medicine Clinical Research Review Board. All data obtained from this study will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: jRCTs051230067.